scholarly journals Assessment and Management of Patients with Chronic Cough by Certified Respiratory Educators: A Randomized Controlled Trial

2009 ◽  
Vol 16 (2) ◽  
pp. 49-54 ◽  
Author(s):  
Stephen K Field ◽  
Diane P Conley ◽  
Amin M Thawer ◽  
Richard Leigh ◽  
Robert L Cowie
Keyword(s):  
Randomized Controlled Trial ◽  
Health Care Professionals ◽  
Chronic Cough ◽  
Controlled Trial ◽  
Controlled Study ◽  
Wait Times ◽  
Screening Process ◽  
Randomized Controlled ◽  
Therapeutic Trials ◽  
Number Of Patients

BACKGROUND: The value of other health care professionals is increasingly being recognized to compensate for the shortage of physicians in Canada. Chronic cough is one of the most common reasons for consultation with a respirologist. In the present study, a prospective, randomized, controlled study was undertaken to determine whether Certified Respiratory Educators (CREs) could manage screened patients with chronic cough as effectively as respirologists.METHODS: An eight-week, prospective, parallel-design, randomized, controlled trial of the management of chronic cough patients was conducted. Patients were screened to exclude those with potentially life-threatening conditions. The primary outcome was the number of patients whose cough resolved or subjectively improved.RESULTS: A total of 198 patients were randomly assigned, and eight-week data were available on 151 patients. Mean age of the patients was 49.8±13.4 years, 70.2% were female and median cough duration was 16 months. The screening process was effective and referral wait times decreased from a median of two months to less than four weeks (P<0.0001). The educators averaged 4.9 contacts per patient compared with 2.7 by the physicians over the eight-week study period (P<0.0001). Most patients had had multiple therapeutic trials before referral. Cough resolved or improved in two-thirds of the patients at eight weeks; however, more patients showed improvement in the educator arm than in the physician arm, P<0.02. Cough-specific quality of life improved similarly in the two study arms at eight weeks (physician arm: 61.5±14.1 to 52.6±14.4, P<0.0001; CRE arm: 58.1±14.9 to 50.0±15.8, P=0.0003).CONCLUSIONS: CREs can safely and effectively assess, as well as appropriately treat, screened patients with chronic cough with a resultant reduction in wait times.

Documenting Patients’ and Providers’ Preferences When Proposing a Randomized Controlled Trial: A Qualitative Exploration

2021 ◽  
Author(s):  
Devesh Oberoi ◽  
Cynthia Kwok ◽  
Yong Li ◽  
Cindy Railton ◽  
Susan Horsman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Design ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Referral Letter ◽  
Care Providers ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Follow Up Care

Abstract Background With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we sought to explore patients’ and OPs’ reactions to our proposed recruitment methods. Methods We used a qualitative study design with content analysis, and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. Results OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. Conclusion OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

Popular diets

2011 ◽  
pp. 213-216
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Potential Harm ◽  
Randomized Controlled ◽  
Scientific Principles

This section is included to help orientate health-care professionals to diets that their patients may initiate or possibly seek advice about. It does not validate their efficacy. For many, evidence of benefit in the form of a randomized controlled trial is not available. However, the concerns, described below, about potential harm resulting from some diets are based on scientific principles....

scholarly journals The effect of cryotherapy on chemotherapy induced oral mucositis in Egyptian cancer patients: A randomized controlled trial

2019 ◽  
Vol 9 (11) ◽  
pp. 63
Author(s):  
Hanan Mohamed Mohamed Soliman
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Oral Mucositis ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Routine Care ◽  
Control Group ◽  
Adverse Side Effect ◽  
Randomized Controlled ◽  
Oral Cryotherapy

Background and objective: Oral Mucositis (OM) is a common adverse side-effect caused by cancer treatments (chemotherapy and/or radiotherapy).  And can lead to mucosa toxicity. Patients with OM may experience extreme pain and may not be able to eat, drink and talk and, as a result, their quality of life is impaired. Treatment and prevention of OM in adult patients treated with chemotherapy are challenging issues for health care professionals. The aim of this study was to evaluate the effect of cryotherapy on incidence and severity of chemotherapy-induced OM and OM related pain in patients treated with combined chemotherapy (Fluorouracil and Leucovorin).Methods: This study is a randomized controlled trial with a random assignment to cryotherapy and control groups. The study was conducted on 40 cancer patients who underwent chemotherapy. The 20 patients in cryotherapy group were received instructions for sucking ice cubes in their mouth for five minutes before, during and shortly after chemotherapy. The 20 patients in control group received routine care. OM and pain severity were evaluated at 7th, 14th and 21st days of the study after chemotherapy using WHO Mucositis grading and-Numeric Pain Rating Scale.Results: In the majority of patients in cryotherapy group, oral Mucositis was not detected (Grade 0) at 7th, 14th and 21st days similarly incidence of grade 1 and 2 of OM in cryotherapy group significantly lowered when compared with control group where p < .001. During the study period, patients in the control group exhibit a significantly higher level of oral discomfort (p = .001).Conclusions: Oral cryotherapy due to its easy administration, tolerability and lack of adverse effects which makes it a very important method for decreasing the severity and incidence of OM and OM associated pain. The oncology nurses have a pivotal role in the application and success of cryotherapy.

scholarly journals Effects of the Proactive Interdisciplinary Self-Management (PRISMA) Program on Online Care Platform Usage in Patients with Type 2 Diabetes in Primary Care: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Esther du Pon ◽  
Nanne Kleefstra ◽  
Frits Cleveringa ◽  
Ad van Dooren ◽  
Eibert R. Heerdink ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Online Platform ◽  
Randomized Controlled ◽  
Number Of Patients

Online care platforms can support patients with type 2 diabetes (T2DM) in managing their health. However, in the use of eHealth, a low participation rate is common. The Proactive Interdisciplinary Self-Management (PRISMA) program, aimed at improving patients’ self-management skills, was expected to encourage patients to manage their disease through the use of an online platform. Therefore, the objective of the current study was to investigate whether a group education program can improve the use of an online care platform in patients with T2DM treated by primary care providers in the Netherlands. In a randomized controlled trial, patients with T2DM received either PRISMA with usual care or usual care only. During a six-month follow-up period in 2014-2015, usage (number of log-ons and time spent per session) of an online care platform (e-Vita) aimed at improving T2DM self-management was assessed. A training about the functionalities of e-Vita was offered. The sample consisted of 203 patients. No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) (X21=0.58; p=0.45), and the number of patients who logged on at least once (platform users) (X21=0.46; p=0.50). In addition, no differences were found between the groups in the type of users—patients who logged on twice or more (active users) or patients who logged on once (nonactive users) (X21=0.56; p=0.45). The PRISMA program did not change platform usage in patients with T2DM. In addition, only a small proportion of the patients logged on twice or more. Patients probably need other encouragements to manage their condition using an online platform.

A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted

2005 ◽  
Vol 119 (4) ◽  
pp. 284-288 ◽  
Author(s):  
Malcolm A Buchanan ◽  
Graham R Dunn ◽  
Gillian M MacDougall
Keyword(s):  
Randomized Controlled Trial ◽  
Local Anaesthetic ◽  
Controlled Trial ◽  
Nasal Surgery ◽  
Double Blind ◽  
Control Power ◽  
Randomized Controlled ◽  
Post Operative Pain ◽  
Number Of Patients ◽  
Significant Difference

To ascertain whether local anaesthetic use is of clinical benefit in nasal surgery, a prospective double-blind randomized controlled trial of topical bupivacaine on post-operative pain in patients packed after bilateral nasal surgery was carried out. Each patient received a bupivacaine-soaked and a saline-soaked Merocel pack, thereby acting as their own control. Power analysis ascertained the number of patients required to enter the trial to detect a statistically significant difference in pain. Fifty-seven patients completed the trial. Visual analogue scales determined the level of post-operative pain at different time points in each nostril. Less pain was demonstrated in nostrils containing bupivacaine-soaked packs compared with saline-soaked packs at two hours (p < 0.0001), four hours (p = 0.0183) and six hours (p = 0.0476) post-operatively. Although not statistically significant, less pain was noted on pack removal on the local anaesthetic sides. These results provide clinical-based evidence for the use of bupivacaine as a local anaesthetic in reducing pain following nasal surgery with packing.

scholarly journals Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Naira Topooco ◽  
Sandra Byléhn ◽  
Ellen Dahlström Nysäter ◽  
Jenny Holmlund ◽  
Johanna Lindegaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
National Level ◽  
Cognitive Behavioral ◽  
Controlled Study ◽  
Control Group ◽  
Depression Symptoms ◽  
Group Effect ◽  
Randomized Controlled

BACKGROUND Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (<italic>P</italic>&lt;.001), corresponding to a large between-group effect (intention-to-treat analysis: <italic>d</italic>=0.86, 95% CI 0.37-1.35; of completer analysis: <italic>d</italic>=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (<italic>P</italic>=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (<italic>P</italic>=.001). CONCLUSIONS The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants’ age and baseline depression severity are of interest in relation to used study methods. CLINICALTRIAL ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205

scholarly journals HYPOfractionated Radiation Therapy Comparing A Standard Radiotherapy Schedule (Over Three Weeks) with A Novel One Week Schedule in Adjuvant Breast Cancer: An Open-Label Randomised Controlled Study (HYPORT- Adjuvant): Study Protocol for a Multicenter, Randomized Phase III Trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

scholarly journals HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open-label randomised controlled study (HYPORT- Adjuvant): study protocol for a multicenter, randomized phase III trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

scholarly journals Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Edyta Ryczek ◽  
Judith White ◽  
Ruth Louise Poole ◽  
Nicola Laura Reeves ◽  
Jared Torkington ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Small Scale ◽  
Perioperative Hypothermia ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Patient Reported

BACKGROUND Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO<sub>2</sub>) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO<sub>2</sub> for insufflation, can reduce the risk of perioperative hypothermia. OBJECTIVE The aim is to determine if insufflation with warmed, humidified CO<sub>2</sub> using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. METHODS The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. RESULTS The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. CONCLUSIONS The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery.

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